Comparative Evaluation of Effectiveness of Moringa Oliefera Capsules and Lycopene Capsules in the Management of Oral Submucous Fibrosis – A Randomized Controlled Trial.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr M Kavinraj
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Evaluation of the following Parameters
Overview
Brief Summary
Oral submucous fibrosis, till date having no definite treatment has been treated with various treatment modalities, which includes the use of various antioxidant and anti-inflammatory therapies. Of all the antioxidants tried in OSMF, lycopene has shown to be an effective antioxidant. There is high reactivity between the long polyene chain and free radicals which enables the elimination of singlet oxygen and the reduction of reactive oxygen species (ROS). But long term use of lycopene may cause lycopenemia, which manifests as deposition of lycopene in liver and orange discolouration of skin. Therefore, newer modalities are needed to be tried in chronic inflammatory conditions like OSMF. Moringa oliefera is a mineral and vitamin rich nutritious and medicinally important tree species. Moringa leaves also has potent antioxidant activity, due to phenolic compounds and flavonoids in it. Oral submucous fibrosis, till date having no definite treatment has been treated with various treatment modalities, which includes the use of various antioxidant and anti-inflammatory therapies. Considering these properties, Moringa oliefera can be considered in the management of OSMF. Also comparing it with lycopene, an effective antioxidant, would further help in better understanding its potential in the management of OSMF.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients in INTERINCISAL OPENING RANGE of 15-35mm.
- •oral sub mucous fibrosis grade1,2,3 acc.to Khanna and Andrade classification (1995).
- •2.No history of prior treatment for the same.
- •3.Patient willing for habit cessation and visit the hospital for regular follow up.
Exclusion Criteria
- •1.Patients with systemic disease.
- •2.Patients with trismus due to other reason (pericoronitis, abscess).
- •3.Presence of other premalignant lesion (leukoplakia, oral lichen planus) or malignancy.
- •4.History of hypersensitivity to moringa oliefera and its components.
- •5.Any tongue abnormalities and disorders.
- •6.Missing upper and lower central incisors 7.Pregnant and lactating mothers.
Outcomes
Primary Outcomes
Evaluation of the following Parameters
Time Frame: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.
1.Maximal interincisal opening using Vernier Caliper.
Time Frame: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.
2.Reduction of burning sensation on the VAS scale
Time Frame: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.
3.Increase in tongue protrusion measured by using steel scale.
Time Frame: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.
4.Cheek flexibility.
Time Frame: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.
Secondary Outcomes
- side effects of intervention if any(Patient will be recalled at the end of 1st week,)
Investigators
Dr M Kavinraj
Government Dental College and Hospital Nagpur